Weekly and Biweekly Treatment With Bofanglutide Versus Semaglutide in Chinese Patients With Type 2 Diabetes : A Phase 2b Randomized Clinical Trial.

BACKGROUND

Bofanglutide is a novel glucagon-like peptide-1 receptor agonist under development for type 2 diabetes mellitus (T2DM) and overweight and obesity.

OBJECTIVE

To evaluate the efficacy and safety of bofanglutide compared with semaglutide.

DESIGN

Phase 2b, randomized, open-label, active-controlled trial. (ClinicalTrials.gov: NCT06256549).

SETTING

Multicenter (37 sites in China).

PARTICIPANTS

Adults with T2DM who were drug-naive or receiving stable oral antidiabetic drugs (glycated hemoglobin A1c [HbA1c], 7.0% to 11.0%).

INTERVENTION: Participants were randomly assigned 1:1:1:1:1 to 1 of 5 treatment groups: bofanglutide titrated to targets of 12, 18, or 24 mg (biweekly [once every 2 weeks; Q2W]); bofanglutide titrated to 24 mg (once weekly [QW]); or semaglutide titrated to 1 mg QW.

MEASUREMENTS: Change in HbA1c level from baseline to week 24 (primary end point), secondary efficacy end points, and safety.

RESULTS

Overall, 272 participants were enrolled, with a mean age of 50.8 years, HbA1c level of 8.35%, and body mass index of 27.9 kg/m2. At week 24, HbA1c level change from baseline was -1.87% (95% CI, -2.11% to -1.63%), -2.28% (CI, -2.54% to -2.03%), and -1.94% (CI, -2.19% to -1.69%) for bofanglutide 12, 18, 24 mg Q2W, respectively; -2.32% (CI, -2.57% to -2.06%) for bofanglutide 24 mg QW; and -1.60% (CI, -1.85% to -1.35%) for 1 mg of semaglutide QW. Corresponding treatment differences versus semaglutide were -0.27% (CI, -0.61% to -0.08%), -0.68% (CI, -1.04% to -0.33%), -0.34% (CI, -0.70% to 0.02%), and -0.72% (CI, -1.08% to -0.36%), respectively. Gastrointestinal adverse events (GIAEs) (mostly grade 1 or 2 in severity) occurred in 81.8% to 87.3% and 51.9% of participants in the bofanglutide and semaglutide groups, respectively. Hypoglycemia occurred in 0% to 3.8% versus 1.9%, with no severe hypoglycemia.

LIMITATION: Open-label, short duration, only Chinese participants.

CONCLUSION

Meaningful reductions in HbA1c levels were seen with bofanglutide in patients with T2DM; GIAEs were the most common and generally manageable.

PRIMARY FUNDING SOURCE: Gan & Lee Pharmaceuticals.